See Important Reminder at the end of this policy for important regulatory and legal information.

Transcription

1 Clinical Policy: (Revatio) Reference Number: CP.PHAR.197 Effective Date: Last Review Date: Line of Business: Commercial, Health Insurance Marketplace, Medicaid Revision Log See Important Reminder at the end of this policy for important regulatory and legal information. Description (Revatio ) is a phosphodiesterase-5 inhibitor. FDA Approved Indication(s) Revatio is indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group 1) in adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when Revatio was added to background epoprostenol therapy. Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class II-III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (25%). Limitation(s) of use: Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity. Policy/Criteria Provider must submit documentation (including such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria. It is the policy of health plans affiliated with Centene Corporation that Revatio is medically necessary when the following criteria are met: I. Initial Approval Criteria A. Pulmonary Hypertension (must meet all): 1. Diagnosis of PAH; 2. Prescribed by or in consultation with a cardiologist or pulmonologist; 3. Failure of a trial of a calcium channel blocker (see Appendix B), unless member meets one of the following (a or b): a. Inadequate response or contraindication to acute vasodilator testing; b. Contraindication or clinically significant adverse effects to a calcium channel blocker are experienced; 4. Dose does not exceed 60 mg/day (oral formulations) or 30 mg/day (intravenous formulations) in divided doses. Approval duration: Medicaid/Health Insurance Marketplace 6 months Commercial Length of benefit Page 1 of 7

2 B. Other diagnoses/indications 1. Refer to the off-label use policy for the relevant line of business if diagnosis is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized): CP.CPA.09 for commercial, HIM.PHAR.21 for health insurance marketplace, and CP.PMN.53 for Medicaid. II. Continued Therapy A. Pulmonary Hypertension (must meet all): 1. Currently receiving medication via Centene benefit or member has previously met all initial approval criteria; 2. Member is responding positively to therapy; 3. If request is for a dose increase, new dose does not exceed 60 mg/day (oral formulations) or 30 mg/day (intravenous formulations) in divided doses. Approval duration: Medicaid/Health Insurance Marketplace 12 months Commercial Length of benefit B. Other diagnoses/indications (must meet 1 or 2): 1. Currently receiving medication via Centene benefit and documentation supports positive response to therapy. Approval duration: Duration of request or 6 months (whichever is less); or 2. Refer to the off-label use policy for the relevant line of business if diagnosis is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized): CP.CPA.09 for commercial, HIM.PHAR.21 for health insurance marketplace, and CP.PMN.53 for Medicaid. III. Diagnoses/Indications for which coverage is NOT authorized: A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies CP.CPA.09 for commercial, HIM.PHAR.21 for health insurance marketplace, and CP.PMN.53 for Medicaid or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FC: functional class FDA: Food and Drug Administration NYHA: New York Heart Association PAH: pulmonary arterial hypertension PH: pulmonary hypertension WHO: World Health Organization Appendix B: Therapeutic Alternatives This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent and may require prior authorization. Page 2 of 7

3 Drug Name Dosing Regimen Dose Limit/ Maximum Dose nifedipine (Adalat CC, 60 mg PO QD; may increase to 240 mg/day Afeditab CR, Procardia, Procardia XL ) 120 to 240 mg/day diltiazem (Dilacor XR, 720 to 960 mg PO QD 960 mg/day Dilt-XR, Cardizem CD, Cartia XT, Tiazac, Taztia XT, Cardizem LA, Matzim LA) amlodipine (Norvasc ) 20 to 30 mg PO QD 30 mg/day Therapeutic alternatives are listed as Brand name (generic) when the drug is available by brand name only and generic (Brand name ) when the drug is available by both brand and generic. Appendix C: Pulmonary Hypertension: WHO Classification Group 1: PAH (pulmonary arterial hypertension) Group 2: PH due to left heart disease Group 3: PH due to lung disease and/or hypoxemia Group 4: CTEPH (chronic thromboembolic pulmonary hypertension) Group 5: PH due to unclear multifactorial mechanisms Appendix D: Pulmonary Hypertension: WHO/NYHA Functional Classes (FC) Treatment Approach* FC Status at Rest Tolerance of Physical Activity PA Limitations Monitoring for progression of PH and treatment of coexisting conditions Advanced treatment of PH with PHtargeted therapy - see Appendix E** I II III IV Comfortable at rest Comfortable at rest Comfortable at rest Dyspnea or fatigue may be present at rest (PA) No limitation Slight limitation Marked limitation Inability to carry out any PA without symptoms Ordinary PA does not cause undue dyspnea or fatigue, chest pain, or near syncope. Ordinary PA causes undue dyspnea or fatigue, chest pain, or near syncope. Less than ordinary PA causes undue dyspnea or fatigue, chest pain, or near syncope. Discomfort is increased by any PA. Heart Failure Signs of right heart failure Page 3 of 7

4 *PH supportive measures may include diuretics, oxygen therapy, anticoagulation, digoxin, exercise, pneumococcal vaccination. **Advanced treatment options also include calcium channel blockers. Appendix E: Pulmonary Hypertension: Targeted Therapies Mechanism of Action Drug Class Drug Subclass Drug Brand/Generic Formulations Prostacyclin* Prostacyclin Epoprostenol Veletri (IV) pathway agonist Flolan (IV) Reduction of pulmonary arterial pressure through vasodilation *Member of the prostanoid class of fatty acid derivatives. Endothelin receptor antagonist (ETRA) Nitric oxidecyclic guanosine monophosphate enhancer Synthetic prostacyclin analog Non-prostanoid prostacyclin receptor (IP receptor) agonist Selective receptor antagonist Nonselective dual action receptor antagonist Phosphodiesterase type 5 (PDE5) inhibitor Guanylate cyclase stimulant (sgc) Treprostinil Iloprost Selexipag Ambrisentan Bosentan Macitentan Tadalafil Riociguat Flolan generic (IV) Orenitram (oral Remodulin (IV) Tyvaso (inhalation) Ventavis (inhalation) Uptravi (oral V. Dosage and Administration Indication Dosing Regimen Maximum Dose Pulmonary arterial hypertension VI. Product Availability Tablets: 20 mg Tablet and oral suspension: 5 mg or 20 mg PO TID, 4-6 hours apart Injection: 2.5 mg or 10 mg TID as an IV bolus Letairis (oral Tracleer (oral Opsumit (oral Revatio (IV, oral tablet, oral suspension) Adcirca (oral Adempas (oral Tablet/oral suspension: 60 mg/day Injection: 30 mg/day Page 4 of 7

5 Oral suspension: 10 mg/ml Vial for injection: 10 mg/12.5 ml VII. References 1. Revatio Prescribing Information. New York, NY: Pfizer Inc.; July Available at Accessed November 21, McLaughlin VV, Archer SL, Badesch DB, et al. ACCF/AHA 2009 expert consensus document on pulmonary hypertension: A report of the American College of Cardiology Foundation Task Force on Expert Consensus Documents and the American Heart Association - developed in collaboration with the American College of Chest Physicians, American Thoracic Society, Inc., and the Pulmonary Hypertension Association. J Am Coll Cardiol. 2009; 53(17): Taichman D, Ornelas J, Chung L, et. al. CHEST guideline and expert panel report: Pharmacologic therapy for pulmonary arterial hypertension in adults. Chest. 2014; 146 (2): Abman SH, Hansmann G, Archer SL, et al. Pediatric pulmonary hypertension: Guidelines from the American Heart Association and American Thoracic Society. Circulation Nov 24; 132(21): Kim NH, Delcroix M, Jenkins DP, et al. Chronic thromboembolic pulmonary hypertension. J Am Coll Cardiol 2013; 62(25): Suppl D Galiè N, Humbert M, Vachiary JL, et al ESC/ERS Guidelines for the diagnosis and treatment of Pulmonary Hypertension. European Heart Journal. Doi: /eurheartj/ehv317. Reviews, Revisions, and Approvals Date P&T Approval Date Policy split from CP.PHAR.33.PAH and converted to new template. Criteria: added specialist requirement; removed echocardiogram as an option for confirming a PH diagnosis; removed hard stop after 3 months of therapy. Appendices removed: 1) examples of calcium channel blocker contraindications; 2) nitrate therapy examples; 3) PAH definition. FC II added to the prostanoid class of PH drugs. Safety criteria were removed unless they 1) represent contraindications or black box warnings not covered by a REMS program, and 2) provide specific lab/imaging parameters that must be met prior to initiation of therapy. An efficacy statement is added to the continuation criteria. Initial and continuation durations increased to 6 and 12 months respectively. Appendices covering PH groups, functional class and therapies reorganized. 1Q18 annual review: Page 5 of 7

6 Reviews, Revisions, and Approvals Date P&T Approval Date - Policies combined for commercial, HIM and Medicaid - No significant changes from previous corporate approved policy. - Medicaid/HIM: removed WHO/NYHA classifications from initial criteria since specialist is involved in care. - References reviewed and updated. Important Reminder This clinical policy has been developed by appropriately experienced and licensed health care professionals based on a review and consideration of currently available generally accepted standards of medical practice; peer-reviewed medical literature; government agency/program approval status; evidence-based guidelines and positions of leading national health professional organizations; views of physicians practicing in relevant clinical areas affected by this clinical policy; and other available clinical information. The Health Plan makes no representations and accepts no liability with respect to the content of any external information used or relied upon in developing this clinical policy. This clinical policy is consistent with standards of medical practice current at the time that this clinical policy was approved. Health Plan means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan s affiliates, as applicable. The purpose of this clinical policy is to provide a guide to medical necessity, which is a component of the guidelines used to assist in making coverage decisions and administering benefits. It does not constitute a contract or guarantee regarding payment or results. Coverage decisions and the administration of benefits are subject to all terms, conditions, exclusions and limitations of the coverage documents (e.g., evidence of coverage, certificate of coverage, policy, contract of insurance, etc.), as well as to state and federal requirements and applicable Health Plan-level administrative policies and procedures. This clinical policy is effective as of the date determined by the Health Plan. The date of posting may not be the effective date of this clinical policy. This clinical policy may be subject to applicable legal and regulatory requirements relating to provider notification. If there is a discrepancy between the effective date of this clinical policy and any applicable legal or regulatory requirement, the requirements of law and regulation shall govern. The Health Plan retains the right to change, amend or withdraw this clinical policy, and additional clinical policies may be developed and adopted as needed, at any time. This clinical policy does not constitute medical advice, medical treatment or medical care. It is not intended to dictate to providers how to practice medicine. Providers are expected to exercise professional medical judgment in providing the most appropriate care, and are solely responsible for the medical advice and treatment of members. This clinical policy is not intended to recommend treatment for members. Members should consult with their treating physician in connection with diagnosis and treatment decisions. Page 6 of 7

7 Providers referred to in this clinical policy are independent contractors who exercise independent judgment and over whom the Health Plan has no control or right of control. Providers are not agents or employees of the Health Plan. This clinical policy is the property of the Health Plan. Unauthorized copying, use, and distribution of this clinical policy or any information contained herein are strictly prohibited. Providers, members and their representatives are bound to the terms and conditions expressed herein through the terms of their contracts. Where no such contract exists, providers, members and their representatives agree to be bound by such terms and conditions by providing services to members and/or submitting claims for payment for such services. Note: For Medicaid members, when state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, state Medicaid coverage provisions take precedence. Please refer to the state Medicaid manual for any coverage provisions pertaining to this clinical policy. For Health Insurance Marketplace members, when applicable, this policy applies only when the prescribed agent is on your health plan approved formulary. Request for non-formulary drugs must be reviewed using the formulary exception policy Centene Corporation. All rights reserved. All materials are exclusively owned by Centene Corporation and are protected by United States copyright law and international copyright law. No part of this publication may be reproduced, copied, modified, distributed, displayed, stored in a retrieval system, transmitted in any form or by any means, or otherwise published without the prior written permission of Centene Corporation. You may not alter or remove any trademark, copyright or other notice contained herein. Centene and Centene Corporation are registered trademarks exclusively owned by Centene Corporation. Page 7 of 7